BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 9717822 · Received February 17, 2020

    Report

    Report Number
    1911916-2020-00152
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 28, 2020
    Report Date
    February 19, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 5 PHOTOS WERE PROVIDED. THEY SHOW A NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD IN SEALED PACKAGING BLISTER. THE LOT# PRINTED ON IS THE LOT# 9093555. THEY SHOW THE TOP AND BOTTOM WEBS FULLY SEALED MAKING DIFFICULT TO SEPARATE THEM AND OPEN THE PACKAGING BLISTER. THIS WOULD HAVE HAPPENED DURING THE MULTIVAC PACKAGING PROCESS. THE BOTTOM WEB IS FORMED TO CREATE A KIND OF NEST AND THE PART IS PLACED IN THE "NEST". THEN THE TOP WEB IS PLACED, AND THE BLISTER IS SEALED. IN THIS CASE BOTH WEBS WERE FULLY SEALED AND NOT DETECTED DURING THE INSPECTIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE FILTER BLUNT FILL 18X1-1/2 PACKAGING DID NOT OPEN PROPERLY PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH. VERBATIM: ¿REPORTING: NEEDLE CAN OFTEN NOT BE OPENED PROPERLY BY PEELING. CONSEQUENCES: A NON-STERILE OPENING WHICH DOES NOT GUARANTEE STERILITY RISKS: INFECTION OR WASTE OF MONEY (BY THROWING AWAY) ¿ THIS COMPLAINT IS CAUTIOUSLY BEING REPORTED BASED ON THE CLIENTS STATEMENT INDICATING A STERILITY BREACH WAS MADE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE FILTER BLUNT FILL 18X1-1/2 PACKAGING DID NOT OPEN PROPERLY PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH. VERBATIM: ¿REPORTING: NEEDLE CAN OFTEN NOT BE OPENED PROPERLY BY PEELING. CONSEQUENCES: A NON-STERILE OPENING WHICH DOES NOT GUARANTEE STERILITY. RISKS: INFECTION OR WASTE OF MONEY (BY THROWING AWAY).¿ THIS COMPLAINT IS CAUTIOUSLY BEING REPORTED BASED ON THE CLIENTS STATEMENT INDICATING A STERILITY BREACH WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182036 NEEDLE FILTER BLUNT FILL 18X1-1/2 BLUNT FILL NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 9093555 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other